The impact of inflammatory bowel disease in Canada: 2012 final report and recommendations [Internet]. Toronto: Crohn’s and Colitis Foundation of Canada; 2012. [cited 2016 Dec 8]. Available from: http://www​.isupportibd​.ca/pdf/ccfc-ibd-impact-report-2012​.pdf

Fast facts: the impact of IBD in Canada 2012 [Internet]. Toronto (ON): Crohn’s and Colitis Foundation of Canada; 2012. [cited 2016 Dec 8]. Available from: http://www​.isupportibd​.ca/pdf/ccfc.ca-impact-report-fast-facts.pdf

Crohn’s disease. Bethesda (MD): National Digestive Diseases Information Clearinghouse; 2014.

Stelara® (ustekinumab): injection 45 mg/0.5 mL, 90 mg/1.0 mL; for injection 130 mg/26 mL(5 mg/mL) [product monograph] [Final]. Toronto (ON): Janssen Inc.; 2016 Dec 12.

Common Drug Review. CADTH Canadian Drug Expert Review Committee (CDEC) final recommendation: Ustekinumab (Stelara - Janssen Inc.). Indication: psoriatic arthritis [Internet]. Ottawa (ON): CADTH; 2014 Oct 20. [cited 2016 Dec 8]. Available from: https://www​.cadth.ca​/sites/default/files​/cdr/complete/cdr_complete​_SR0359_Stelara_Oct-22-14.pdf

Common Drug Review. CEDAC final recommendation and reasons for recommendation: Ustekinumab (Stelara™ - Janssen-Ortho Inc.). Indication: chronic moderate to severe plaque psoriasis [Internet]. Ottawa (ON): CADTH; 2009 Jun 17. [cited 2016 Dec 8]. Available from: https://www​.cadth.ca​/sites/default/files​/cdr/complete/cdr_complete​_Stelara_June-17-2009.pdf

Clinical study report CNTO1275CRD3001. A phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety and efficacy of ustekinumab induction therapy in subjects with moderately to severely active Crohn’s disease who have failed or are intolerant to TNF antagonist therapy [CONFIDENTIAL internal manufacturer’s report]. Raritan (NJ): Janssen Research & Development, LLC; 2015.

Clinical study report CNTO1275CRD3002. A phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety and efficacy of ustekinumab induction therapy in subjects with moderately to severely active Crohn’s disease [CONFIDENTIAL internal manufacturer’s report]. Raritan (NJ): Janssen Research & Development, LLC; 2015.

Clinical study report CNTO1275CRD3003. A phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety and efficacy of ustekinumab maintenance therapy in subjects with moderately to severely active Crohn’s disease [CONFIDENTIAL internal manufacturer’s report]. Raritan (NJ): Janssen Research & Development, LLC; 2015.

Clinical study report C0743T26. A phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of ustekinumab therapy in subjects with moderately to severely active Crohn’s disease previously treated with TNF antagonist therapy: CERTIFI (Crohn’s Evaluation of Response to Ustekinumab anti-IL12/23 for Induction) [CONFIDENTIAL internal manufacturer’s report]. Raritan (NJ): Janssen Research & Development; 2011.

Sandborn WJ, Gasink C, Gao LL, Blank MA, Johanns J, Guzzo C, et al. Ustekinumab induction and maintenance therapy in refractory Crohn’s disease. N Engl J Med. 2012 Oct 18;367(16):1519–28. [PubMed: 23075178]

Cornerstone Research Group. Stelara® for the treatment of moderate to severe Crohn’s disease: network meta-analysis study report [CONFIDENTIAL internal manufacturer’s report]. Burlington (ON): Cornerstone Research Group;

Singh S, Garg SK, Pardi DS, Wang Z, Murad MH, Loftus EV, Jr. Comparative efficacy of biologic therapy in biologic-naive patients with Crohn disease: a systematic review and network meta-analysis. Mayo Clin Proc. 2014 Dec;89(12):1621–35. [PubMed: 25441399]

Mocko P, Kawalec P, Pilc A. Safety profile of biologic drugs in the therapy of Crohn disease: a systematic review and network meta-analysis. Pharmacol Rep. 2016 Aug 1;68(6):1237–43. [PubMed: 27686963]

Mocko P, Kawalec P, Pilc A. Safety profile of biologic drugs in the therapy of Crohn disease: a systematic review and network meta-analysis [supplementary material]. Pharmacol Rep. 2016 Aug 1;68(6):1237–43. [PubMed: 27686963]

Lichtenstein GR, Hanauer SB, Sandborn WJ, The Practice Parameters Committee of the American College of Gastroenterology. Management of Crohn’s disease in adults. Am J Gastroenterol. 2009;104:465–83. [PubMed: 19174807]

Vedolizumab 300mg powder for concentrate for solution for infusion (Entyvio^©). Takeda UK Ltd [Internet]. Glasgow (GB): Scottish Medicines Consortium; 2015 Jun 5. [cited 2016 Dec 8]. Available from: https://www​.scottishmedicines​.org.uk/files​/advice/vedolizumab​_Entyvio_FINAL_June_2015_for_website​.pdf

Inflectra^T (infliximab): powder for solution, sterile, lyophilized, 100 mg/vial [product monograph]. Incheon, South Korea: Celltrion Healthcare Ltd.; 2016 Jun 10.

Remicade^© (infliximab): powder for solution, sterile, lyophilized, 100 mg/vial [product monograph]. Toronto: Janssen Inc.; 2016 Apr 26.

Humira^© (adalimumab): 40 mg in 0.8 mL sterile solution (50 mg/mL) subcutaneous injection [product monograph]. St. Laurent (QC): AbbVie Corporation; 2016 Apr 6.

Common Drug Review. CEDAC final recommendation and reason for recommendation. Adalimumab resubmission #3 (Humira^© - Abbott Laboratories Ltd.) [Internet]. Ottawa (ON): CADTH; 2007 Dec 19. [cited 2016 Dec 8]. Available from: https://www​.cadth.ca​/sites/default/files​/cdr/complete/cdr_complete​_Humira-Resubmission-Crohns​_Dec-19-2007.pdf

Common Drug Review. Adalimumab (Humira^© - Abbott Laboratories Limited). Indication - Crohn’s disease: overview of CDR clinical and pharmacoeconomic reports [Internet]. Ottawa: CADTH; 2008. [cited 2016 Dec 8]. Available from: https://www​.cadth.ca​/sites/default/files​/cdr/relatedinfo/cdr​_trans_humira-resub3-crohns​_overview_Mar-07-08_e.pdf

Common Drug Review. CADTH Canadian Drug Expert Committee (CDEC) final recommendation: Infliximab (Inflectra - Hospira Healthcare Corporation). Indication: Crohn disease and ulcerative colitis [Internet]. Ottawa (ON): CADTH; 2016 Oct 25. [cited 2016 Dec 8]. Available from: https://www​.cadth.ca​/sites/default/files​/cdr/complete/SE0483​_IBD_Inflectra-Oct-28-16.pdf [PubMed: 30516937]

EntyvioT (vedolizumab) powder for concentrate for solution in infusion 300 mg/vial [product monograph]. Oakville (ON): Takeda Canada; 2016 Mar 22.

Feagan BG, Sandborn WJ, Gasink C, Jacobstein D, Lang Y, Friedman JR, et al. Ustekinumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2016 Nov 17;375(20):1946–60. [PubMed: 27959607]

CDR submission: Stelara (ustekinumab), solution for infusion 130 mg/26 mL, 90 mg/1.0 mL solution for injection. Company: Janssen Inc. [CONFIDENTIAL manufacturer’s submission]. Toronto (ON): Janssen Inc.; 2016 Sep 12.

Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics. 1975 Mar;31(1):103–15. [PubMed: 1100130]

Revised protocol C0743T26. A phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of ustekinumab therapy in subjects with moderately to severely active Crohn’s disease previously treated in TNF antagonist therapy. Study name: CERTIFI (Crohn’s Evaluation of Response to Ustekinumab anti-IL 12/23 for Induction) [CONFIDENTIAL internal manufacturer’s report]. Malvern (PA): Centocor Inc.; 2009.

Clinical protocol - Amendment 3. Protocol CNTO1275CRD3003. A phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety and efficacy of ustekinumab maintenance therapy in subjects wtih moderately to severely active Crohn’s disease [CONFIDENTIAL internal manufacturer’s report]. Raritan (NJ): Janssen Research & Development; 2015.

Clinical protocol - Amendment 3. Protocol CNTO1275CRD3001. A phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety and efficacy of ustekinumab induction therapy in subjects wtih moderately to severely active Crohn’s disease who have failed or are intolerant to TNF antagonist therapy [CONFIDENTIAL internal manufacturer’s report]. [Raritan (NJ)]: Janssen Research & Development; 2013.

Clinical protocol - Amendment 3. Protocol CNTO1275CRD3002. A phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety and efficacy of ustekinumab induction therapy in subjects with moderately to severely active Crohn’s disease [CONFIDENTIAL internal manufacturer’s report]. Raritan (NJ): Janssen Research & Development; 2014.

Guyatt G, Mitchell A, Irvine EJ, Singer J, Williams N, Goodacre R, et al. A new measure of health status for clinical trials in inflammatory bowel disease. Gastroenterology. 1989 Mar;96(3):804–10. [PubMed: 2644154]

Irvine EJ. Development and subsequent refinement of the inflammatory bowel disease questionnaire: a quality-of-life instrument for adult patients with inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 1999 Apr;28(4):S23–S27. [PubMed: 10204520]

Gregor JC, McDonald JW, Klar N, Wall R, Atkinson K, Lamba B, et al. An evaluation of utility measurement in Crohn’s disease. Inflamm Bowel Dis. 1997;3(4):265–76. [PubMed: 23282873]

Coteur G, Feagan B, Keininger DL, Kosinski M. Evaluation of the meaningfulness of health-related quality of life improvements as assessed by the SF-36 and the EQ-5D VAS in patients with active Crohn’s disease. Aliment Pharmacol Ther. 2009 May 1;29(9):1032–41. [PubMed: 19222413]

User’s manual for the SF-36v2 health survey. 3rd ed. Lincoln (RI): Quality Metric Incorporated; 2011.

Tang K, Beaton DE, Boonen A, Gignac MA, Bombardier C. Measures of work disability and productivity: Rheumatoid Arthritis Specific Work Productivity Survey (WPS-RA), Workplace Activity Limitations Scale (WALS), Work Instability Scale for Rheumatoid Arthritis (RA-WIS), Work Limitations Questionnaire (WLQ), and Work Productivity and Activity Impairment Questionnaire (WPAI). Arthritis Care Res (Hoboken) [Internet]. 2011 Nov [cited 2016 Dec 5];63 Suppl 11:S337–S349. Available from: http:​//onlinelibrary​.wiley.com/doi/10.1002/acr.20633/pdf [PubMed: 22588755]

Lerner D, Amick BC, III, Lee JC, Rooney T, Rogers WH, Chang H, et al. Relationship of employee-reported work limitations to work productivity. Med Care. 2003 May;41(5):649–59. [PubMed: 12719689]

Lerner D, Amick BC, III, Rogers WH, Malspeis S, Bungay K, Cynn D. The Work Limitations Questionnaire. Med Care. 2001 Jan;39(1):72–85. [PubMed: 11176545]

Tamminga SJ, Verbeek JH, Frings-Dresen MH, De Boer AG. Measurement properties of the Work Limitations Questionnaire were sufficient among cancer survivors. Qual Life Res. 2014 Mar;23(2):515–25. [PubMed: 23893345]

Verhoef JA, Miedema HS, Bramsen I, Roebroeck ME. Using the work limitations questionnaire in patients with a chronic condition in the Netherlands. J Occup Environ Med. 2012 Oct;54(10):1293–9. [PubMed: 22995808]

Daperno M, D’Haens G, Van AG, Baert F, Bulois P, Maunoury V, et al. Development and validation of a new, simplified endoscopic activity score for Crohn’s disease: the SES-CD. Gastrointest Endosc. 2004 Oct;60(4):505–12. [PubMed: 15472670]

Colombel JF, Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Panaccione R, et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn’s disease: the CHARM trial. Gastroenterology. 2007 Jan;132(1):52–65. [PubMed: 17241859]

Rutgeerts P, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, et al. Comparison of scheduled and episodic treatment strategies of infliximab in Crohn’s disease. Gastroenterology. 2004 Feb;126(2):402–13. [PubMed: 14762776]

Dignass A, Van AG, Lindsay JO, Lemann M, Soderholm J, Colombel JF, et al. The second European evidence-based consensus on the diagnosis and management of Crohn’s disease: current management. J Crohns Colitis. 2010 Feb;4(1):28–62. [PubMed: 21122489]

Committee for Medicinal Products for Human Use. Guideline on the development of new medicinal products for the treatment of Crohn’s disease [Internet]. London (GB): European Medicines Agency; 2008 Jul 24. [cited 2016 Dec 21]. Available from: http://www​.ema.europa​.eu/docs/en_GB/document_library​/Scientific_guideline​/2009/09/WC500003265.pdf

Guidance for industry: adaptive design clinical trials for drugs and biologics: draft guidance [Internet]. Silver Spring (MD): Food and Drug Administration; 2010. [cited 2016 Dec 8]. Available from: http://www​.fda.gov/downloads/Drugs/​.../Guidances/ucm201790​.pdf

Sipponen T, Nuutinen H, Turunen U, Farkkila M. Endoscopic evaluation of Crohn’s disease activity: comparison of the CDEIS and the SES-CD. Inflamm Bowel Dis. 2010 Dec;16(12):2131–6. [PubMed: 20848462]

Khanna R, Nelson SA, Feagan BG, D’Haens G, Sandborn WJ, Zou GY, et al. Endoscopic scoring indices for evaluation of disease activity in Crohn’s disease. Cochrane Database Syst Rev. 2016 Aug 8;(8):CD010642. [PMC free article: PMC7079710] [PubMed: 27501379]

Sadowski DC, Bernstein CN, Bitton A, Croitoru K, Fedorak RN, Griffiths A, et al. Canadian Association of Gastroenterology clinical practice guidelines: the use of tumour necrosis factor-alpha antagonist therapy in Crohn’s disease. Can J Gastroenterol [Internet]. 2009 Mar [cited 2016 Dec 21];23(3):185–202. Available from: https://www​.cag-acg.org​/images/publications​/cag_cpg_crohnsmar2009.pdf [PMC free article: PMC2694654] [PubMed: 19319383]

Prescribing information: Cimzia (certolizumab pegol) injection, for subcutaneous use [Internet]. Smyrna (GA): UCB Pharma S.A.; 2016. [cited 2016 Dec 8]. Available from: http://www​.accessdata​.fda.gov/drugsatfda_docs​/label/2016/125160s241lbl.pdf

Sandborn WJ. Crohn’s disease evaluation and treatment: clinical decision tool. Gastroenterology. 2014 Sep;147(3):702–5. [PubMed: 25046160]

Committee for Medicinal Products for Human Use. European public assessment report: Entyvio [Internet]. London (GB): European Medicines Agency; 2014 Mar 20. [cited 2016 Dec 21]. Available from: http://www​.ema.europa​.eu/docs/en_GB/document_library​/EPAR_-_Public​_assessment_report​/human/002782/WC500168530.pdf

Summary of the risk management plan (RMP) for Entyvio (vedolizumab) [Internet]. London (GB): European Medicines Agency; 2014. [cited 2016 Dec 8]. Available from: http://www​.ema.europa​.eu/docs/en_GB/document_library​/EPAR_-_Risk-management-plan_summary​/human/002782/WC500163289.pdf

Abbreviated health technology assessment report of ustekinumab maintenance of efficacy in Crohn’s disease through 2 years. Protocol CNTO1275CRD3003. A phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety and efficacy of ustekinumab maintenance therapy in subjects with moderately to severely active Crohn’s disease [CONFIDENTIAL internal manufacturer’s report]. Raritan (NJ): Janssen Research & Development, LLC; 2016.

Stelara (ustekinumab): EPAR product information [Internet]. London (GB): European Medicines Agency; 2016 Nov 25. [cited 2017 Jan 2]. Available from: http://www​.ema.europa​.eu/docs/en_GB/document_library​/EPAR_-_Product_Information​/human​/000958/WC500058513.pdf

Best WR, Becktel JM, Singleton JW, Kern F Jr. Development of a Crohn’s disease activity index. National Cooperative Crohn’s Disease Study. Gastroenterology. 1976 Mar;70(3):439–44. [PubMed: 1248701]

Yoshida EM. The Crohn’s Disease Activity Index, its derivatives and the Inflammatory Bowel Disease Questionnaire: a review of instruments to assess Crohn’s disease. Can J Gastroenterol. 1999 Jan;13(1):65–73. [PubMed: 10099817]

Sandborn WJ, Feagan BG, Hanauer SB, Lochs H, Lofberg R, Modigliani R, et al. A review of activity indices and efficacy endpoints for clinical trials of medical therapy in adults with Crohn’s disease. Gastroenterology. 2002 Feb;122(2):512–30. [PubMed: 11832465]

Mahadevan U. Clinical trial design and endpoints in biologic therapy for Crohn’s disease: interpretation of the results. In: Medscape [Internet]. New York (NY): WebMD; 2006 [cited 2016 Jul 11]. Available from: http://www​.medscape.com​/viewarticle/543353 Free registration required.

Best WR, Becktel JM, Singleton JW. Rederived values of the eight coefficients of the Crohn’s Disease Activity Index (CDAI). Gastroenterology. 1979 Oct;77(4 Pt 2):843–6. [PubMed: 467941]

de Dombal FT, Softley A. IOIBD report no 1: Observer variation in calculating indices of severity and activity in Crohn’s diseaes. International Organisation for the Study of Inflammatory Bowel Disease. Gut [Internet]. 1987 Apr [cited 2017 Jan 25];28(4):474–81. Available from: http://www​.ncbi.nlm.nih​.gov/pmc/articles/PMC1432811 [PMC free article: PMC1432811] [PubMed: 3583074]

Pallis AG, Mouzas IA, Vlachonikolis IG. The inflammatory bowel disease questionnaire: a review of its national validation studies. Inflamm Bowel Dis. 2004 May;10(3):261–9. [PubMed: 15290922]

Irvine EJ, Feagan B, Rochon J, Archambault A, Fedorak RN, Groll A, et al. Quality of life: a valid and reliable measure of therapeutic efficacy in the treatment of inflammatory bowel disease. Canadian Crohn’s Relapse Prevention Trial Study Group. Gastroenterology. 1994 Feb;106(2):287–96. [PubMed: 8299896]

Bernklev T, Jahnsen J, Lygren I, Henriksen M, Vatn M, Moum B. Health-related quality of life in patients with inflammatory bowel disease measured with the short form-36: psychometric assessments and a comparison with general population norms. Inflamm Bowel Dis. 2005 Oct;11(10):909–18. [PubMed: 16189421]

Beaton DE, Tang K, Gignac MA, Lacaille D, Badley EM, Anis AH, et al. Reliability, validity, and responsiveness of five at-work productivity measures in patients with rheumatoid arthritis or osteoarthritis. Arthritis Care Res (Hoboken) [Internet]. 2010 Jan 15 [cited 2016 Dec 5];62(1):28–37. Available from: http:​//onlinelibrary​.wiley.com/doi/10.1002/acr.20011/pdf [PubMed: 20191488]

Walker N, Michaud K, Wolfe F. Work limitations among working persons with rheumatoid arthritis: results, reliability, and validity of the work limitations questionnaire in 836 patients. J Rheumatol. 2005 Jun;32(6):1006–12. [PubMed: 15940759]

A phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety and efficacy of ustekinumab maintenance therapy in subjects with moderately to severely active Crohn’s disease. Protocol CNTO1275CRD3003; phase 3: Stelara® (ustekinumab) [CONFIDENTIAL internal manufacturer’s report]. Raritan (NJ): Janssen Research & Development; 2016.

Dias S, Sutton AJ, Ades AE, Welton NJ. Evidence synthesis for decision making 2: a generalized linear modeling framework for pairwise and network meta-analysis of randomized controlled trials. Med Decis Making [Internet]. 2013 Jul [cited 2017 Mar 29];33(5):607–17. Available from: http://www​.ncbi.nlm.nih​.gov/pmc/articles/PMC3704203 [PMC free article: PMC3704203] [PubMed: 23104435]

Jansen JP, Fleurence R, Devine B, Itzler R, Barrett A, Hawkins N, et al. Interpreting indirect treatment comparisons and network meta-analysis for health-care decision making: report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices: part 1. Value Health. 2011 Jun;14(4):417–28. [PubMed: 21669366]

Peyrin-Biroulet L, Panes J, Sandborn WJ, Vermeire S, Danese S, Feagan BG, et al. Defining disease severity in inflammatory bowel diseases: current and future directions. Clin Gastroenterol Hepatol. 2016 Mar;14(3):348–54. [PubMed: 26071941]